Clinical Research Directory

Phase 3 Trial Evaluating the Efficacy and Safety of Cytisinicline for Vaping Cessation in Adults Using Nicotine-Containing E Cigarettes

This will be a multi-center, double-blind, randomized, placebo-controlled, Phase 3 study conducted in male or female adults who are daily nicotine e-cigarette users only. A total of approximately 800 subjects will be randomly assigned (1:1) to one of two Arms: * Arm B, 12 weeks cytisinicline + behavior support: N=400 or * Arm A, 12 weeks of placebo+ behavior support: N=400) The primary objective is to assess whether subjects randomized to Arm B (3 mg cytisinicline TID for 12 weeks plus behavioral support) have a higher probability of nicotine vaping cessation from Week 9 to Week 12 as compared to subjects randomized to Arm A (placebo TID for 12 weeks plus behavioral support).

Parents Helping Parents for Youth Vaping Cessation

The goal of this randomized controlled study is to test if this new intervention works to help adolescents quit vaping. A key feature of the program is the use of peer support for parents, delivered by trained parent coaches. Participants will complete baseline and follow up surveys. Parents in the intervention arm will receive peer support as part of the program.

Implementing an Adolescent and Young Adult (AYA) mHealth Vaping Cessation Program Into Oncology Clinics

The purpose of this study is to understand e-cigarette use and interest in quitting by exploring e vaping behaviors among a cohort of AYA survivors (N=500). The investigators will also examine demographic, medical, and psychosocial factors associated with vaping behaviors. Primary Objectives: Phase 1. * Objective 1. Identify characteristics of adolescent and young adult childhood cancer survivors (AYA CCS) nicotine vaping behaviors (e.g., e-cigarette use, interest in quitting, and quit attempts) and associations with demographic (e.g., sex, race, socioeconomic status, LGBTQ+ identification), cancer-specific (e.g., diagnosis, treatment factors), and psychosocial and behavioral factors. * Objective 2. Develop strategies to improve implementation of an evidence-based, mHealth vaping cessation program within an AYA oncology clinic. * Objective 2a: Use qualitative interviews to explore patient preferences regarding program implementation (e.g., timing of assessment of vaping behavior, confidentiality, referral approach) and identify barriers to uptake. * Objective 2b: Interview and/or ask healthcare providers (e.g., practitioners, advanced practice providers, social workers practicing in AYA oncology settings) to complete open- ended questionnaires related to current processes (e.g., workflow), needs, and barriers for assessing e-cigarette use and vaping cessation referral processes. Evaluate healthcare providers' information needs, preferences, and tools needed for integrating e- cigarette assessment and cessation program referrals into current practice. Phase 2. * Objective 3. Develop and test vaping assessment and referral implementation processes (developed from Objectives 1 \& 2)., and uptake of an established mHealth vaping cessation program * Objective 3a: Using qualitative and quantitative measures, we will assess the reach (% of eligible AYA CCS that enrolled in mHealth program), adoption (% providers making referrals), strategy potential (provider/patient perceptions of referral process; appropriateness of program for patients), and maintenance (barriers/facilitators to implementation) of the program.

Developing an E-Cigarette Cessation Intervention for Hispanic/Latina(o) Youth in Florida: The BReATHE Study

Investigators will create and implement an e-cigarette intervention for Hispanic/Latino (H/L) high school youth. Focus groups with the target population (i.e., H/L high school students) and meetings with a community advisory board (CAB) will inform this intervention. The intervention will be tested with 120 H/L high school e-cigarette users to assess feasibility and promise for reducing use.

Mindful Breaths: Mindfulness for Young Adult Vaping

The goal of this clinical trial is to evaluate the feasibility, acceptability, and preliminary efficacy of mindfulness-based interventions (MBI) as a vaping cessation intervention in young adults aged 18-29 who vape nicotine at least 25 days per month and are interested in cutting down or quitting. The main questions it aims to answer are: * Can mindfulness practice reduce nicotine cravings in young adults? * Is mindfulness practice an acceptable and feasible intervention for vaping cessation in this population? Researchers will compare participants in the mindfulness intervention group to a control group that watches a video with calming music and images to see if mindfulness practice has a greater effect on reducing nicotine cravings. Participants will: * Complete a baseline survey and craving cue reactivity assessment. * Engage in a 10-minute guided mindfulness meditation (intervention group) or view calming music and images (control group). * Rate their cravings and the acceptability, appropriateness, and feasibility of the intervention after the session.

Nicotine Patch Plus Nicotine Mouth Spray Versus Nicotine Reduction for Vaping Cessation

This research focuses on maximizing the chances of successfully quitting vaping. A large, pragmatic community-based clinical trial is planned in New Zealand to build on existing evidence from previous vaping and smoking cessation research undertaken by the study team. The effectiveness of combination nicotine replacement therapy (NRT) compared to nicotine tapering on vaping abstinence has not yet been investigated, but both provide an opportunity to increase success with vaping cessation, especially when combined with written behavioural support to further boost quit rates. The planned trial will test whether using combination NRT will help more New Zealanders to quit vaping long-term, compared with a vape nicotine tapering plan. Participants in both groups will also receive written vaping cessation behavioural support.